Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 11:28 AM
Study NCT ID:
NCT03863951
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2019-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poststroke Depression of Clinical Trial Registration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2019-02-24', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Composition of Intestinal Microbial Communities Calculated by OTU Analysis', 'timeFrame': '2 weeks', 'description': 'The composition were measured in number based on OTU data'}, {'measure': 'The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis', 'timeFrame': '2 weeks', 'description': 'Community diversity measured in the Shannon index'}, {'measure': 'The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score', 'timeFrame': '3 months', 'description': 'Mild depression（HAMD-17 Score\\>7，≤17）, moderate depression（HAMD-17 Score\\>17，≤24）, major depression（HAMD-17 Score\\>24）'}, {'measure': 'Functional Independence Assessed by Modified Rankin Scale (mRS）score', 'timeFrame': '3 months', 'description': 'MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\\>2), and death (mRS score = 6).'}], 'secondaryOutcomes': [{'measure': 'The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods', 'timeFrame': '2 weeks', 'description': '5-HT measured in mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'depression', 'intestinal microbiota'], 'conditions': ['Stroke', 'Depression']}, 'descriptionModule': {'briefSummary': 'The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.', 'detailedDescription': 'In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'acute ischemic stroke patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,\n* has no history of depression or use of antidepressants or antipsychotics,\n* were competent to consent to take part in this research.\n\nExclusion Criteria:\n\n* significant acute or severe illness such as infection,heart failure and tumor,\n* previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,\n* antibiotics in the last two weeks,\n* severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,\n* a previous history of neurological illness including AD and PD，\n* Inflammatory bowel disease，'}, 'identificationModule': {'nctId': 'NCT03863951', 'acronym': 'IFEPSDAIS', 'briefTitle': 'Poststroke Depression of Clinical Trial Registration', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2018-024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with poststroke depression', 'description': 'No intervention'}, {'label': 'Patients without poststroke depression', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yurong Zhang', 'role': 'CONTACT', 'email': 'zhangyurong72@mail.xjtu.edu.cn'}], 'facility': 'Yurong Zhang', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yurong Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangyurong72@mail.xjtu.edu.cn', 'phone': '0086-029-85323443'}], 'overallOfficials': [{'name': 'Yurong Zhang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}